Colon CancerNCT06852495
the Effect of Environmental Factors on Colorectal Cancer Based on Macrogenomes
An observational study of Colon Cancer and Rectal Cancer, run by Dong Peng at 1 site in China.
Trial summary
The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with colorectal cancer by pathological biopsy and healthy participants with no history of malignancy were included in the study.
Who may be able to join
- Age ≥18 years old;
- Patients diagnosed with colorectal cancer by pathologic biopsy before surgery;
- Patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
- Willing to participate in the study and sign an informed consent form. Complete clinical data.
Who cannot join
- Concurrent primary malignant tumor other than colorectal cancer;
- Patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan;
- Inappropriate for enrollment as assessed by the investigator;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: A Study of Colorectal Cancer Development and Prognosis Based on Environmental Factors and Macrogenomes
The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal cancer, Macrogenome, Environmental pollution, air pollution
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the colorectal cancer group | patients diagnosed with colorectal cancer | |
| the control group | Healthy individuals with no history of malignant tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis
Overall survival (OS), from date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first.
Measured: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months
Secondary outcomes (1)
Macrogenomic differences
Macrogenomic differences in feces.
Measured: The date of macrogenomic testing, assessed up to 1 week after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852495
- Sponsor's protocol ID
- 2024-443-01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Colorectal Cancer Development and Prognosis Based on Environmental Factors and Macrogenomes
- ClinicalTrials.gov ID
- NCT06852495
- Acronym / sponsor ID
- 2024-443-01
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal cancer, Macrogenome, Environmental pollution, air pollution
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the colorectal cancer group | – | –patients diagnosed with colorectal cancer |
| the control group | – | –Healthy individuals with no history of malignant tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorectal cancer by pathological biopsy and healthy participants with no history of malignancy were included in the study.
Key inclusion criteria (4 listed)
- Age ≥18 years old;
- Patients diagnosed with colorectal cancer by pathologic biopsy before surgery;
- Patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
- Willing to participate in the study and sign an informed consent form. Complete clinical data.
Key exclusion criteria (4 listed)
- Concurrent primary malignant tumor other than colorectal cancer;
- Patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan;
- Inappropriate for enrollment as assessed by the investigator;
- Incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prognosis
Time frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months
Overall survival (OS), from date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first.
1 secondary outcome
Macrogenomic differences
Time frame: The date of macrogenomic testing, assessed up to 1 week after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No. Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by Dong Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis (time frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.